Pharmacovigilance and Drug Safety

Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy.

 

  • Track 1-1 Evaluate the safety of drug and therapeutic biologic products
  • Track 2-2 Analyse safety signals
  • Track 3-3 Recommend regulatory actions
  • Track 4-4 Communicate relevant safety information
  • Track 5-5 Adverse event reporting
  • Track 6-6 Individual Case Safety Report
  • Track 7-7 Pharmacoepidemiology

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